to: enable regulations to be made prescribing an annual charge for a conformity assessment body determination payable by the Australian corporation that is the subject of the determination; provide that the obligation for a conformity assessment body to pay an annual charge continues during a period in which the conformity assessment body determination is suspended; and ensure that the annual charges prescribed for provisionally registered goods also apply to provisionally registered goods entered in the Australian Register of Therapeutic Goods.

Introduced with the Therapeutic Goods (Charges) Amendment Bill 2017, the bill amends the

Therapeutic Goods Act 1989

to: introduce a new approval pathway for prescription medicines by creating a class of therapeutic good to be known as ‘provisionally registered goods’; allow the minister to specify, by legislative instrument, permitted indications for use with listed medicines; establish an additional pathway for intermediate risk medicines through a new application and assessment process for sponsors of listed complementary medicines seeking to use indications that fall outside the permitted indications list; strengthen monitoring powers in relation to biologicals; implement stronger compliance and enforcement powers and graduated penalties for non-compliant behaviours; remove the distinctions between advertisements for therapeutic goods for which an approval is, or is not, required; enable the secretary to utilise the work of comparable overseas regulators in the course of making assessments of medical devices; enable the secretary to publish information in relation to Australian conformity assessment bodies; align the secretary’s powers relating to conformity assessment certificates issued by Australian conformity assessment bodies and conformity assessment certificates issued by the secretary; clarify that the secretary has the power to refuse an application for including medicines, biologicals and medical devices in the Australian Register of Therapeutic Goods prior to evaluating the application if it does not meet the application requirements; and make minor amendments to achieve consistency of regulatory requirements between different types of therapeutic goods and make other minor changes; and

to: require trustees to assess on an annual basis whether the outcomes that are being delivered by MySuper products are promoting the financial interests of MySuper members; allow the Australian Prudential Regulation Authority (APRA) to refuse, or cancel, an authority to offer a MySuper product if it has a reason to believe the registrable superannuation entity (RSE) licensee may fail to comply with its obligations; impose civil and criminal penalties on directors of RSE licensees who fail to execute their responsibilities to act in the best interests of members, or who use their position to further their own interests to the detriment of members; enable APRA to refuse authority for a change in ownership or control where it has concerns about the person seeking ownership or control, give a direction to a person to relinquish control of a RSE licensee and remove or suspend an RSE licensee where it is subject to the control of its owner; align APRA’s directions powers in relation to the superannuation industry with its broader directions powers in the banking and insurance industries; and require RSE licensees to hold annual members’ meetings;

Corporations Act 2001

and

Superannuation Industry (Supervision) Act 1993

to require superannuation funds to disclose on a semi-annual basis investments that they hold directly or through associated entities and initial investments into non-associated entities;

Financial Sector (Collection of Data) Act 2001

to provide APRA with the ability to obtain information on expenses incurred by RSE and RSE licensees in managing or operating the RSE; and

to: provide that employees under workplace determinations or enterprise agreements made on or after 1 July 2018 have the right to choose their superannuation fund; and provide that amounts sacrificed under an employee salary sacrifice arrangement will not reduce an employer’s mandated superannuation guarantee contributions.

and 12 other Acts to introduce a new external dispute resolution scheme, known as the Australian Financial Complaints Authority (AFCA), to resolve disputes about products and services provided by financial firms; and five Acts to: require firms that must participate in the enhanced internal dispute resolution (IDR) framework to report their IDR activities to the Australian Securities and Investments Commission (ASIC) in accordance with ASIC requirements; provide ASIC with additional powers to determine the content and form of IDR reporting by IDR Firms and to publish this data at both the aggregate and firm level; and allow ASIC to specify, by legislative instrument, requirements for trustees and retirement savings account providers to provide written reasons for decisions in relation to complaints. Also repeals the

to: remove the five-voyage minimum requirement to apply for a temporary licence; allow the minister to determine that consultation must be undertaken on the movement of certain kinds of cargoes and passengers when applied for under a temporary licence or a variation to a temporary licence; create a single variation process for temporary licences; provide that notifications are only required when voyage details have changed from that approved on a licence; amend the tolerance provisions for temporary licence voyages; allow for temporary licences to be issued in emergency situations; amend the definition of ‘coastal trading’ to include voyages commencing and concluding at the same port, ships engaged in dry-docking, and voyages between ports and other defined places in Australian waters; allow vessels to be covered by a coastal trading licence while dry-docking; clarify that applications for a variation to a temporary licence must be made by the temporary licence holder and that agents may apply for a temporary licence on behalf of vessel owners or masters; and require temporary licence holders to provide a vessel’s International Maritime Organization number in voyage reports; and

to: insert community safety as a factor that can be taken into account to revoke the parole of a federal offender without notice; remove the requirement to seek leave before a recorded interview of a vulnerable witness can be admitted as evidence in chief; remove the requirement for vulnerable witnesses to be available to give evidence at committal proceedings; introduce mandatory minimum penalties for certain Commonwealth child sex offences and offenders; require a court to state and record the reasons for granting bail; insert a presumption against bail for certain Commonwealth child sex offenders; insert additional factors which must be taken into account when sentencing federal offenders; require the court to have regard to certain rehabilitation considerations when sentencing Commonwealth child sex offenders; insert presumptions in favour of cumulative sentences and actual terms of imprisonment for Commonwealth child sex offenders; impose certain requirements on Commonwealth child sex offenders under a recognizance release order; add ‘residential treatment orders’ as a sentencing alternative for intellectually disabled offenders; allow certain information to be withheld from an offender in national security circumstances; reduce the amount of ‘clean street time’ that can be credited against the outstanding sentence following commission of an offence by a person on parole and license; require a period of time to be served in custody if a federal offender’s parole order is revoked;

Criminal Code Act 1995

to: clarify the scope of the definition of ‘engage in sexual activity’; insert a range of new aggravated offences for child sexual abuse; insert new offences relating to ‘grooming’ and the provision of electronic services to facilitate dealings with child abuse material online; increase the maximum penalties for certain Commonwealth child sex offences and breaches of reporting requirements; and insert new additional factors for mandatory consideration at sentencing; and

to: introduce new offences for a person recklessly or intentionally representing themselves to be, or to be acting on behalf of, or with the authority of, a Commonwealth entity or service; and introduce a new injunction power to allow authorised persons to seek injunctive relief to prevent a person from engaging in conduct in contravention of the new offences.